Suppository or bougie



Patented June15, 1943 sorrosrroa' R BOUG IE Grover C. Miller, SanGabriel, Calif., assignor to Gromiller, Inc., Los An tion of CaliforniaNo Drawing.

7 Claims.

The bases of such suppositories and bougies are commonly and easilyfusible cones or cylinders of cocoa butter, soap, or gly'cerinatedgelatin. Because of this easily fusible character of the bases of whichthese articles are made, tremendous losses are incurred annually by bothmanufacturer, seller and user. In the more temperate localities, andparticularly in the warmer climates wherein the temperatures often reachabove the body temperatures, the bases of these articles fuse, withconsequent destruction. For a great many years this diificulty has beenrecognized, both my manufacturers, wholesalers, retailers and users.Most users hesitate to place such articles in private refrigerators, andmany losses have occurred because of sudden temperature increases andthe failure of handlers of'such articles to have available adequaterefrigeration facilities. Patients endeavor to avoid the use of sucharticles where they can only be properly handled in refrigerators, andtherefore they lose the beneficial applications possible'through thismethod of application. There has to my knowledge been no adequatesolution heretofore found for this problem.

I have discovered a base composition for such articles which ispractically unaffected by heat changes but which may be made to fuseeasily and equally effectively in the presence of moisture. I have foundfurther that this base material may carry any desired or requiredmedicament and may be caused to fuse and release the medicament asdesired by the control of the constituents of the composition of whichthe base is formed.

I have further discovered that by incorporation in the base of myinvention of suitable quantitles of hygroscopic substances such asglycerine that I am able to control the moisture present to cause theeffective fused disintegration or expanding as the case may be of thebase of these articles to release the medicaments as desired or toproduce a desired dilative suppository where medication is not desired.

geles, Calif., a corpora- Application October 30, 1939,- Serial No.301,952

. sired medicaments over a period of time.

It is therefore an object of my invention .to provide a base forsuppository, bougie, or the like which is substantially unaffected byheat changes but which will readily fuse in the presence of moisture.

It is another object of my invention to provide a .base composition fora suppository or bougie which will readily fuse under the influence ofmoisture and which is so combined with a substance of hygroscopiccharacter as to control the moisture to enable the control of thefusing, disintegration or dilative characteristics of the suppository orbougie.

It is another object of my invention to provide a base for a suppositoryor bougie which includes a material which, under the influence ofmoisture will cause the said bougie to fuse or disintegrate so as torelease any'medicament as carried in said base.

Another object of my invention is to provide 'a base material for theholding of the desired medicaments for the formation of suppositories orlike substances and which suppositories or like substances as formedwill be substantially heat resistant and unaffected by ordinary ordrastic temperature changes.

Other objects and advantages of this invention it is believed will beapparent from the hereinafter set forth detailed explanation thereof asapplied to the several modifications thereof.

In accordance with my invention, the base for a suppository is formedwhich is resistant to fusing under temperature changes but which willreadily fuse in the presence of moisture or will expand or disintegrateunder the said influence, depending upon the particular composition ofthe product and its desired applicability, that is, substances of thischaracter are manufactured both for their dilative effect and fordelivering de- Thus the particular type of product utilized woulddetermine the particular application, whether of an expansible characteror one which disintezrates or fuses in its application.

As an example of the coating embodying my invention wherein the base isof thedisintegrating character, I form the base in the proportions of:

In this combination the stearic acid and agar proportions aredeterminative of therate of absorption of water, as is the degree ofsubdivision to which the agar is powdered. The availability of water forabsorption by the agar is controlled 4 by the quantity of the waterabstracting substance which here is set forth as glycerin. Any othersuitable water abstracting substance may be utilized and the proportionsas herein set forth are not critical but are determinative of the rateat which the substance will disintegrate to release the medicament. Itwill be obvious that these proportions may be varied over wide rangesand that the varying of the proportions of one substance permits a likevariation of the proportions of the others.

While we have in this example and in the other examples set forthstearic acid as one of the principal base materials, any other similarmaterial may be utilized in the preparations which will with thedisintegrating element, 1. e., agar,

be determinative of the rate at which the water will be taken up by theagar. Other oils, waxes or similar substances may be utilized.

The manner of combining the ingredients is merely the manner of suitablemixing to obtain a homogeneous mass. Thus the powdered substances, i.e., the powdered agar and powdered stearic acid, are placed in a massmixing machine and mixed together, at which time the medicament may beadded, particularly if a powdered medicament is used. After the dryingredients have been mixed, the wet ingredients such as the glycerinmay be added and mixing continued until the same is all complete andhomogeneously mixed together. If a liquid medicament is utilized, it maybe most conveniently added with the glycerin to the dry mixedsubstances.

In this preparation the disintegration or fusing of the base of thesuppository or bougie is. caused by the water as absorbed by the agar.The water is made available to the agar for absorption by the ability ofthe water abstracting substance glycerin to take water from itssurroundings. Thus, the quantity, of agar, the quantity of glycerin, andthe protection offered to the agar by the stearic acid determines therate at'which the base material will disintegrate under the influence ofthe moisture to release the medicament carried thereby.

In this type of preparation a water abstracting substance of thecharacter of glycerin appears to be essential in order to bring intocontact with the base material a sufficient amount of water to cause therapid fusing of the base material to liberate the medicament as rapidlyas is desired. This, however, depends to'a considerable degree upon therate at which the medicament is desired and the time within which itisrdesired to release the medicament. It will be obvious from theforegoing that many substances other than agar are utilizable. Thus anysubstance which has the property of expanding rather Such substances},

diate absorption of water with consequent andimmediate disintegration ofthe base material.

Thus many types of this material may be utilized among which arecarnauba wax, stearic acid, petroleum Jelly, either mixed as desired orseparately, depending upon the control desired of the water absorption.With the ingredients properly mixed, they are then preferably sub-Jected to. suitable pressure in suitable molds in order to form the sameinto the desired cylinders or cones or balls of such shape as may bedesired in the particular application.

In some cases it is found advantageous to glaze the surface of thecylinders, cones or balls. Such glazing may be accomplished in a numberof ways, for example, by mixing into the product an alcoholic solutionof candy glaze, white shellac, or the like, prior to, or during,pressure-forming of the said articles.

As a separate and further example, and particularly as an example of theexpanding type of suppository or bougie which does not readilydisintegrate, the following is given:

3 parts of powdered stearic acid are mixed with one part of powderedokra. After these substances have been thoroughly mixed, or during themedicament being added in the manner as indicated.

After the suppository or bougie is formulated under the pressure of thiscomposition, it will be found that the same gradually expands as wateris absorbed by the powderedokra without substantial disintegration. Thusan expanding or dilative type of suppository or bougie is provided fromwhich the medicament is released during the period of expansion.

A further example of my invention is found in the use of powdered elm inplace of powdered agar, the first examplegiven. In this type ofstructure the base material will be partially of the expanding andpartially of the disintegrating type. In this case 15 parts of powderedstearic acid are mixed with 10 parts of powdered elm and 3 parts ofglycerin. The mixing, the forming and medication of the base materialmay be the same as set forth in connection with the first example aboveset forth. In this case it is advisable to glaze the formed materialwith an alcoholic solution of a candy glaze, white shellac, or the like,in order to cause the particles under pressure to more closely adhere.When this base material is utilized, it will be found that it hascharacteristics of both the disintegrating and expansible types in thatit fuses both through expansion and disintegration as the water isabsorbed.

As a further example of this invention. powdered stearic acid in twoparts may be mixed with one part powdered pectin and 2 parts ofglycerin. This mixture may be handled in substantially the same manneras hereinabove set forth, both as to mixing, medication and forming.This particular preparation has one added advantage not present to-sucha marked degree iii the other preparations set forth, and that is, ofproviding a mucilaginous substance as the water is absorbed and thepectin swells to cause disintegration of the base materialwithconsequent liberation of the medicament.

A further example of my invention is found in the mixing of stearicacid, carnauba wax, petroleum jelly, with powdered agar and suflicientalcohol to form a paste. In this modification the stearic acid, carnaubawax and petroleum jelly are melted, cooled,*pulverized, and then mixedin a suitable mixing machine with the powdered agar and alcohol andmixing is continued until the mass is a homogeneous paste. During thismixing glycerin is added in suflicient quantity to draw the moisture outof the tissue so that it may be absorbed by the agar. This mixture tendsto give a more water impervious base material by more thoroughlyprotecting the agar from water and may act to slow up the rate of waterabsorption by the powdered agar.

As heretofore set forth, any other suitable substance may be used in theplace of glycerin, as the water abstracting agent and which product orsubstance has the property of drawing moisture from the surroundingtissue so that the suppository or bougie will fuse or disintegrate inthe proper period of time. As an example of such other substances whichmay be used in place of glycerin, there is potassium acetate and otherdeliquescent products. An example of the preparation utilizing potassiumacetate in the place of glycerin is prepared from two parts of powderedstearic acid, two parts of powdered agar, two parts of potassiumacetate, and one part of alcohol, mixed together to produce a moistpowder which is then compressed into the shape desired in the ordinarysuppository-preparing machines.

- Having fully described my invention, it is to be understood that I donot wish to be limited to the details herein set forth, but my inventionis of the full scope of the appended claims.

I claim:

1. A solid base material for suppositories, bougies or the like, whichis substantially unaffected by heat at body temperature but which willab-- stract moisture from surrounding tissue and release a medicament inthe presence of said abstracted moisture at a desired rate, consistingof a water absorbing agent selected from the group consisting ofpowdered agar, elm, cinnamon' bark, cornmeal, thyme, kaolin, -psylliumseeds, bentonite clay,,okra and pectin; a water absorption retardingagent selected from the group consisting of petroleum jelly, carnaubawax, and powdered stearic acid; and a water abstracting agent selectedfrom the group consisting of glycerine and potassium acetate.

2. A base material for suppositories, bougies or the like, which issubstantially unaflected by heat at body temperature but which willabstract moisture from surrounding tissue and fuse in the presence ofsaid abstracted moisture and release a medicament at a desired rate,consisting of the following materials in about the proportionsspecifled: 2 parts of powdered stearic acid; 1 part of powdered agar;and 2 parts of glycerin.

3. A base material for suppositories, bougies or the like, which issubstantially unafiected by heat at body temperature but which willabstract moisture from surrounding tissue and fuse in the presence ofsaid abstracted moisture and release a medicament at a desired rate,consisting of the following materials in about the proportionsspecified: 2 parts of powdered stearic acid; 1 part of powdered pectin;and 2 parts of glycerin.

4.. A base material for a dilative type suppository, bougie or the like,which is substantially unaifected by heat at body temperature but whichwill abstract moisture from surrounding tissue and expand in thepresence of said abstracted moisture and release a medicament at adesired rate, consisting of the following materials in about theproportions specified: 3 parts of powdered stearic acid: 1 part of okra;and glycerin in the ratio of about 2% of the total mixture of stearicacid, dry agar, and glycerin in such relative proportions that themixture is substantially unaffected by heat at body temperature but iscapable of abstracting moisture from surrounding tissue and releasingthe medicament at a desired rate in the presence of said abstractedmoisture.

6. As an article of commerce, a suppository, bougie or the like,consisting of a medicament, stearic acid, dry agar, and glycerin in suchrelative proportions that the mixture is substantially unaffected byheat at body temperature but is capable of abstracting moisture fromsurrounding tissue and fusingand releasing the medicament at a desiredrate in the presence of said abstracted moisture.

7. As an article of commerce, a suppository, bougie or the like,consisting of a medicament,

powdered stearic acid, powdered okra, an'd glycthepresence of saidabstracted moisture during the period of expansion.

GROVER C. MIR-ER.

